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YY/T 1764-2021: (Test method of axial, bending and torsion durability of blood vessel stent in vitro)
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(Test method of axial, bending and torsion durability of blood vessel stent in vitro)
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YY/T 1764-2021
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Basic data | Standard ID | YY/T 1764-2021 (YY/T1764-2021) | | Description (Translated English) | (Test method of axial, bending and torsion durability of blood vessel stent in vitro) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Word Count Estimation | 27,271 | | Issuing agency(ies) | State Drug Administration | YY/T 1764-2021: (Test method of axial, bending and torsion durability of blood vessel stent in vitro)
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(Test method of axial, bending and torsion durability of blood vessel stent in vitro)
ICS 11.040.30
C30
People's Republic of China Pharmaceutical Industry Standard
In vitro axial, bending and torsional durability of vascular stents
testing method
Published on 2021-09-06
2022-09-01 Implementation
Released by the State Drug Administration
directory
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Test Method Summary 2
5 Meaning and use 2
6 Specimen size, configuration and preparation 3
7 General equipment requirements4
8 General test parameters 4
9 Test report 6
Appendix A (Normative Appendix) Axial Durability of Vascular Stents8
Appendix B (Informative Appendix) Bending Durability of Vascular Stents. Axial Compression Bending 12
Appendix C (Informative Appendix) Bending Durability of Vascular Stents. Mandrel Bending 15
Appendix D (Informative) Bending Durability of Vascular Stents. Arc Bending Without Mandrel 18
Appendix E (Normative Appendix) Torsion Durability of Vascular Stents 21
Reference 23
foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This standard is proposed by the State Drug Administration.
This standard is approved by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices Subcommittee on Cardiovascular Implants (SAC/TC
110/SC2) focal point.
This standard was drafted by. Shanghai MicroPort Cardiovascular Technology Co., Ltd., Tianjin Medical Device Quality Supervision and Inspection Center, Medon
Power (Shanghai) Management Co., Ltd.
The main drafters of this standard. Jin Guocheng, Feng Xiaoyu, Guo Yangyang, Wu Xiaowu, Zhang Zhenghui, Miao Hui, Jiao Yongzhe, Chen Huimin.
In vitro axial, bending and torsional durability of vascular stents
testing method
1 Scope
This standard specifies three independent cyclic deformation durability tests related to vascular stents. axial, bending and torsional. The three tests
Both model the effect of non-radial arterial motion on stent durability that may originate from musculoskeletal activities, including walking and breathing, to
and cardiac exercise.
This standard applies to balloon-expandable and self-expanding stents made of metal or alloys, including coated stents (e.g., with
superficial stents), single polymer stents or absorbable stents, as well as stents for the treatment of aneurysmal disease, peripheral vascular injury, or to provide vascular access
Endovascular prostheses (stent grafts), and this standard applies to the testing of the above-mentioned stents (or a representative part of the stents).
This standard does not apply to the testing of alternatives, although durability testing of alternatives (such as scaled-up partial support structures) may
Provide useful information.
Note 1.This standard does not cover flat, local extrusion durability or multi-mode testing. Although this standard does not cover multimodal testing, the information described in the text can
Help build multimodal tests.
Note 2.For the treatment of aneurysm disease, peripheral vascular injury, or other tubular products to provide vascular access can refer to this standard.
Note 3.This standard does not provide in vivo physiological deformation conditions for vascular stents. In these durability tests, develop and justify these boundary conditions (e.g.
such as literature studies, in vivo studies, cadaveric studies or modeling of stent-vascular interactions) is the responsibility of the standard user. Other than that, it may be necessary to consider
Conditions include vascular calcification, vascular taper, eccentric lesions, loading offsets (eg, motion), and vascular remodeling.
Note 4.This standard does not specify the specific properties of the test product.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
pieces. For undated references, the latest edition (including all amendments) applies to this document.
YY/T 0808-2010 Standard test method for in vitro pulsation durability of vascular stents
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
axial
Linear compression or tension along the longitudinal axis of the stent and/or simulated vessel.
3.2
bent bending
Deformation of the longitudinal axis of the stent and/or simulated vessel to achieve a specific stent radius of curvature.
3.3
torsional torsional
Stenting and/or simulating twisting of the longitudinal axis of the vessel.
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